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| with almost every significant key opinion leader in the field and they have experience with the drug, I think, would also be a big positive in terms of potential adoption of the therapy commercially |
| These salutations provide important advantages that might expedite regulatory review of enva |
| So based on our market research and achieving our target product profile, we do feel that envafolimab would be adopted by the investigators that are currently using it in the clinical trial which is another advantage for us |
| We believe that over time, our PDP has earned strong credibility as a compelling solution for companies who wish to become CRO-independent and reap the rewards of conducting trials faster at higher quality and at lower cost compared to trials typically contracted to CROs |
| As a typical CRO charges $300,000 or more per patient, the potential savings from licensing our PDP on a 100-patient trial could be up to approximately $20 million for our partner in addition to the expected advantages of increased speed of trial execution and pace of enrollment that we enjoy at TRACON by running trials using our in-house team |
| And I would point out, we were net income-positive both in quarter 4 and also quarter 3 related to leveraging the platform |
| Our goal in ENVASARC is to demonstrate that enva has potential to be both safer and more efficacious than Votrient, a drug with a black-box warning for fatal liver toxicity |
| As has been the experience at TRACON, we believe such an investment can result in substantial time and cost savings for our partner |
| As we have noted in the past, we expect to further supplement our cash position through opportunities for non-dilutive capital enabled through our CRO independent PDP that we believe positions us as one of the most efficient clinical development organizations |
| Enva monotherapy was generally well tolerated without a single drug-related serious adverse event |
| Second, we expect to continue to leverage our product development platform to generate non-dilutive capital through either an additional license or through fees captured by replacing a CRO and executing clinical trials for partners at a lower cost compared to a CRO but still at a premium to our cost using a pay-for-performance model |
| And potential revenue through licensing or leveraging the platform could result in further quarters in the future where we're actually income-positive |
| Our clinical development strategy is designed to create the opportunity for enva to broadly benefit patients with sarcoma in the frontline, adjuvant and neoadjuvant settings by seeking supplemental BLAs |
| We executed a license of our PDP for an upfront payment of $3 million in November of last year to a biotech company that recognized the value of internalizing its clinical operations to reap the benefits of CRO independent clinical trial implementation that we enjoy at TRACON |
| So that will decrease expenses going forward as well |
| So based on our market research of achieving our target product profile which is a 15% response rate, we actually expect significant adoption of the therapy |
| As a reminder, we have received Fast Track designation for enva in the sarcoma subtypes of UPS and MFS that have progressed on 1 or 2 prior lines of therapy and received orphan drug designation in soft tissue sarcoma based on activity observed in ENVASARC |
| Have a great day |
| If we can go to that company and say, we'll guarantee the price at $30 million, knowing we can do it at $10 million, you can see that's substantial potential revenue for TRACON |
| The increase in revenue for the 3-month period is related to the PDP license for $3 million and the increase in the 12-month period is due to the prespecified $9 million termination fee for the TJ4309 license in conjunction with the previously announced arbitration outcome with I-Mab |
| The primary endpoint of the trial is progression-free survival and the trial is designed to detect an improvement in progression-free survival at 1 year from 56% to 75% |
| But to be clear, the opportunity for having Cohort D in the study was potentially to have dual approval |
| Scott Brown Thank you, Charles and good afternoon, everyone |
| And thank you to the audience for your time and attention and we look forward to updating you next quarter |
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| Our net income was $0.4 million for the 3 months ended December 31, 2023 and our net loss was $3.6 million for the 12 months ended December 31, 2023, compared to net losses of $7 million and $29.1 million for the comparable periods of 2022 |
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